gattex kit Drug Patent Profile
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Which patents cover Gattex Kit, and when can generic versions of Gattex Kit launch?
Gattex Kit is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has eight patent family members in seven countries.
The generic ingredient in GATTEX KIT is teduglutide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the teduglutide profile page.
DrugPatentWatch® Generic Entry Outlook for Gattex Kit
Gattex Kit was eligible for patent challenges on December 21, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 16, 2026. This may change due to patent challenges or generic licensing.
There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
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Questions you can ask:
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Summary for gattex kit
International Patents: | 8 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 16 |
Clinical Trials: | 12 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for gattex kit |
DailyMed Link: | gattex kit at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for gattex kit
Generic Entry Date for gattex kit*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT NDA:
Dosage:
POWDER;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for gattex kit
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Allegheny Singer Research Institute | Phase 3 |
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | Phase 3 |
Daniel Dante Yeh | Phase 2 |
Pharmacology for gattex kit
Ingredient-type | Analogs/Derivatives Glucagon-Like Peptide 2 |
Drug Class | GLP-2 Analog |
Mechanism of Action | Glucagon-like Peptide-2 (GLP-2) Agonists |
Paragraph IV (Patent) Challenges for GATTEX KIT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
GATTEX KIT | Injection | teduglutide | 5 mg/vial | 203441 | 1 | 2016-12-21 |
US Patents and Regulatory Information for gattex kit
gattex kit is protected by two US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of gattex kit is ⤷ Subscribe.
This potential generic entry date is based on TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | GATTEX KIT | teduglutide | POWDER;SUBCUTANEOUS | 203441-001 | Dec 21, 2012 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Takeda Pharms Usa | GATTEX KIT | teduglutide | POWDER;SUBCUTANEOUS | 203441-001 | Dec 21, 2012 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Takeda Pharms Usa | GATTEX KIT | teduglutide | POWDER;SUBCUTANEOUS | 203441-001 | Dec 21, 2012 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for gattex kit
See the table below for patents covering gattex kit around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2008518941 | ⤷ Subscribe | |
European Patent Office | 1809318 | TRAITEMENT DE PATIENTS ATTEINTS DU SYNDROME DE L'INTESTIN COURT AVEC COLON EN CONTINUITE (TREATMENT OF SHORT BOWEL SYNDROME PATIENTS WITH COLON-IN-CONTINUITY) | ⤷ Subscribe |
Japan | 4149497 | ⤷ Subscribe | |
World Intellectual Property Organization (WIPO) | 9632414 | ⤷ Subscribe | |
Hong Kong | 1147761 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for gattex kit
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0906338 | 2013/006 | Ireland | ⤷ Subscribe | PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830 |
0906338 | CA 2013 00012 | Denmark | ⤷ Subscribe | |
0906338 | 13C0013 | France | ⤷ Subscribe | PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830 |
0906338 | C300578 | Netherlands | ⤷ Subscribe | PRODUCT NAME: TEDUGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE FORM THEREOF; REGISTRATION NO/DATE: EU/1/12/787/001 20120830 |
0906338 | 92153 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: TEDUGLUTIDE SOUS TOUTES SES FORMES, TELLES QU ELLES SONT PROTEGEES PAR LE BREVET DE BASE |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Gattex kit Market Analysis and Financial Projection Experimental
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